July 10, 2018
Clinical Trial Recruitability: The New Standard for Patient-Centricity
How a small shift in focus can have big impacts in recruitment and retention
“Feasibility” has become an umbrella term, applied to site selection criteria as well as protocol development and even patient-experience analysis – but it shouldn’t be. A “feasibility” perspective on patient recruitment (and the insights gathering, creative development, media funneling, and physician referral processes that support it) does not serve the industry or the patients well.
What we really mean is not feasibility but recruitabilityTM, and that’s a distinction that’s worthy of some reflection.
What’s the difference between feasibility and recruitability?
Feasibility asks whether or not a site has a database of patients that fit the incidence and prevalence criteria for the indication being studied – not whether or not the site can reasonably recruit those patients. Recruitability considers the accuracy of a site’s patient population and data, their motivations for involvement in the study, and the ability to drive patients to that site for the study.
Feasibility asks whether or not a protocol can be executed, technically-speaking. Recruitability challenges the protocol and asks whether or not it’s necessary, for example, that 8 spinal taps be built into the visits, or whether or not caregivers or healthcare practitioners are reasonably likely to sign their loved ones up for a study that will require multiple blood draws from patients who already have fragile veins.
“Feasibility is about understanding convenience. Recruitability is about understanding people. Both are about what’s possible – but recruitability includes the human factor, and it’s the most important factor of all.”
Feasibility thinks of patient recruitment as a means to drug commercialization, filling seats in a trial. Recruitability understands that even a thoughtful protocol, reviewed by KOLs with input from advocacy, can fail to consider the patient journey if the right insights were not gathered up front.
Feasibility is about understanding convenience. Recruitability is about understanding people.
Both are about what’s possible – but recruitability includes the human factor, and it’s the most important factor of all.
Implementing Recruitability as the New Standard
The mental shift from feasibility to recruitability may be a simple enough transition to make – but operationalizing it requires planning and a commitment to patent-centricity that, while it has clear long-term benefits and efficiencies, can still feel like a hurdle if you don’t have the right partner guiding you along the way.
It all starts with asking the right questions, and the earlier you commit to getting answers to those questions, the better. So, what drives patients to enroll in a clinical trial? To a degree, this varies by patient and is influenced by existing treatment options, severity of the disease state, access to standard of care, and other factors that aren’t in our control. And it’s because there is a list of factors outside of our control that we have to focus especially closely on what is in our control – such as the protocol, the messaging of patient materials, the attitudes of healthcare practitioners, and the experience at the site. These components require thoughtful consideration – not feasibility, but recruitability.
Is the protocol recruitable? In a perfect world, you’d be asking yourself that question during development. Of course feasibility is important – you can’t execute a protocol that’s not physically possible or that won’t provide you the data you require for your endpoints and milestones. But you also won’t get patients to enroll in your trial if you don’t consider their journey and the journeys of caregivers or spouses involved in getting them to the site visits. Does your site visit include time for lunch? Is it a patient population that has a high prevalence of smokers, but your site visits don’t allow for smoke breaks? Are you asking patients not to eat or drink for hours before the study without considering that their disease state or study drug makes their mouths dry?
Can the site be recruitable? You already have access to loads of data suggesting which sites will successfully be able to recruit patients. But do those sites have WiFi? Are there children’s toys or a TV in the waiting room? Is the location in an area that supports Lyft or other ride-sharing services, or even public transportation? Is there a deli or grocery store nearby so that your patients can get lunch?
Why are patients leaving the trial early? If you didn’t implement the recruitability concepts in your protocol design or site selection, you can still gather relevant insights and make meaningful amendments if necessary while a trial is underway. Even small shifts at the individual site levels or tweaks to the protocol (including implementation of lunch or smoking breaks, like we mentioned before) can have profound effects on retention. If you can’t make any adjustments to the current protocol, exit interviews can help you make changes to the protocol for the next phase.
There are many moving parts to manage in the process of patient recruitment – you’ll be much more successful with a specialist on your side. Gathering impactful patient, site, and/or HCP insights before committing to sites and protocols will take time and money, but the benefits you will realize by using those insights to enroll patients on time and keep them in the study for the duration of the protocol are worth the investment.
If you’re serious about patient-centricity (and you should be), then commit to recruitability. Commit to a partner who has experience operationalizing these concepts – we believe you’ll see measurable benefits not only for the trial at hand, but for future trial phases, and for your company as a whole.
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